A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

NCT ID: NCT04187300

Last Updated: 2021-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2020-09-23

Brief Summary

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DV3396

Semaglutide administered with the DV3396 pen-injector (Formulation D)

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks

PDS290

Semaglutide administered with the PDS290 pen-injector (Formulation B)

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks

Interventions

Semaglutide

Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 27.0 and 34.9 kg/m^2 (both inclusive)
• Body weight between 70.0 and 130.0 kg (both inclusive)

Exclusion Criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
• Inability or unwillingness to perform self-injection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

Other Identifiers

U1111-1236-7697

Identifier Type: OTHER

Identifier Source: secondary_id

2019-002909-21

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9536-4590

Identifier Type: -

Identifier Source: org_study_id